** W2 only - Not available for C2C/1099 consulting **
** PLEASE NOTE - Short-term contract (4 months) **
Start Date: ASAP
Position Overview
The Regulatory Information Management (RIM) Consultant is responsible for supporting the Regulatory Affairs Department, and leading the electronic management and storage of critical Regulatory submissions, documents, and correspondence. This position involves understanding/ensuring adherence to applicable regulatory requirements, internal and external stakeholder collaboration. This position will report into the Regulatory Project Management function and requires experience with Electronic Document Management System (EDMS), Regulatory Information Management (RIM) system, Regulatory publishing activities, and IT systems.
Job Functions/Responsibilities:
- Serve as Business Owner for Veeva Vault RIM system
- Manage logistics/archival related to global Health Authority submissions
- Serve as RA Lead for key collaborations with publishing and other Regulatory Systems vendors, as needed
- Partner with colleagues in IT, Regulatory, and QA to process system enhancements/change controls.
- Ensure processes are in place for system maintenance & operation
- Oversee & control the life cycle of Regulatory IT systems, as assigned
- Provide user training & user support to use systems efficiently
- Ensure continued & improved overall user satisfaction with systems
Qualifications:
- Bachelor’s Degree in a scientific discipline or equivalent experience
- 5-10 years of experience in the pharmaceutical industry, including 3-5 years in Regulatory Affairs
- Experience managing Veeva RIM and EDMS required
- Knowledge and demonstrated experience in relevant US/EU/ICH Regulations (e.g., eCTD format, GxP regulations), Regulatory publishing tools, and IT/EDMS systems (e.g., maintenance and/or implementation)
- Experience in 21 CFR Part 11 compliance/other electronic registration systems requirements
- Experience in supporting & troubleshooting regulatory systems
- Experience working with managed services and/or offshore teams
Knowledge, Skills, & Abilities:
- Strong verbal and written communication
- Demonstrated ability to lead internal/external collaborations
- xEVMPD data submission experience is highly desired
- Experience with Veeva Vault Connectors is preferred
